Atlas FDA

Cook Endoscopy

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usag recall (Z-2691-2011)Cook Endoscopy2011-06-28
DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Sale recall (Z-0925-2011)Cook Endoscopy2011-01-19
DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical recall (Z-0926-2011)Cook Endoscopy2011-01-19
Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station R recall (Z-0091-2011)Cook Endoscopy2010-10-19
Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station R recall (Z-0092-2011)Cook Endoscopy2010-10-19
Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous recall (Z-1910-2009)Cook Endoscopy2009-09-01
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, recall (Z-1598-2009)Cook Endoscopy2009-07-21
AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4 recall (Z-1059-2009)Cook Endoscopy2009-03-10
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Betha recall (Z-0325-2009)Cook Endoscopy2009-01-05
Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Leng recall (Z-0113-2009)Cook Endoscopy2008-10-14
Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposab recall (Z-2331-2008)Cook Endoscopy2008-09-23
Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use recall (Z-2332-2008)Cook Endoscopy2008-09-23
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bet recall (Z-0520-2007)Cook Endoscopy2007-02-22
Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, recall (Z-0160-2007)Cook Endoscopy2006-11-08
Cook Esophageal Dilator Set --------------------------------------Small label applied by O recall (Z-0848-06)Cook Endoscopy2006-05-06
SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable recall (Z-0441-06)Cook Endoscopy2006-01-25

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Every clearance here is in the API, with alerts when new ones post.